It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation’s abbreviated marketing pathway for biosimilar products.

On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral arguments on the last day of the Court’s October 2016 Term, as we previously reported. With respect to both of the significant issues presented, the Justices unanimously reversed the Federal Circuit Court of Appeals split opinion and remanded for further consideration of questions related to State law.

Although our intellectual property colleagues have separately analyzed the “Patent Dance” implications of the Court’s decision in Amgen v. Sandoz (see here), the second issue presented in the case related to the proper interpretation of the 180-day notice provision of the Biologics Price Competition and Innovation Act (“BPCIA”). The Federal Circuit had held that such notice by the biosimilar applicant can only be provided to the reference product sponsor after FDA licenses (i.e., approves) the biosimilar application. Continue Reading SCOTUS Ruling Gives a Boost to Biosimilars; FDA Continues to Advance Products Through AdComs

In another highly anticipated regulatory move, FDA has released draft guidance on “Labeling for Biosimilar Products.” Made public on March 31st, the draft guidance sets forth FDA’s recommendations on the labeling of biosimilar products that are approved via the abbreviated licensure pathway created in 2010 by the BPCIA. The Agency has been under pressure for many months now to issue some sort of policy on biosimilar labeling, whose contours will have dramatic impacts on the growth and development of this industry in the United States.

Many stakeholders have been critical of last year’s final labeling package for Zarxio (filgrastim-sndz), the first biosimilar approved in the U.S., because that labeling was essentially identical to the labeling for the reference filgrastim product, Amgen’s Neupogen. Biologic manufacturers (such as AbbVie, who in December filed a Citizen Petition with FDA regarding the scope and content of biosimilar labels) have cited concerns that labeling for a biosimilar should not be “the same as” the reference biologic’s label in the same way that generic drug labels are generally the same as their reference listed drug product’s label. These industry stakeholders, along with certain patient and provider groups, argue that biosimilars should not be treated the same as generic drugs because the statutory standard for FDA approval is that a biosimilar be “highly similar” to its reference and have “no clinically meaningful” differences compared to the reference biologic – a different approval standard than what small-molecule generic drugs have under the Hatch-Waxman Act. On the other hand, FDA also received another Citizen Petition late last year that requested generic drug-style labeling for the biosimilar class of products.

Therefore, a key aspect of the newly issued draft guidance is the extent to which biosimilar labeling should be consistent with the label of the reference product. FDA is not requiring biosimilar labels to be identical to its reference product; however, it proposes that biosimilar labels should heavily rely upon their reference products. Specifically, FDA states in the draft guidance: Continue Reading FDA Differentiates Biosimilar Labeling from Generic Drug Labeling

As our regular readers know, we’ve been tracking regulatory approvals, reimbursement policies, pharmacy substitution laws, and other developments related to biosimilar biological products. Biosimilars rely on the safety and efficacy history of an existing biological product for FDA approval by demonstrating that the biosimilar is “highly similar” to the reference product. Recent weeks have been busy ones for state and federal officials involved in this area, and certainly the same can be said for developers of biosimilar products who need to keep pace with these rapid developments.

State Substitution Laws

As the 2016 State Legislative Session enters full swing (indeed, a few regular sessions have already adjourned for the year), we expect that more states will join Puerto Rico and the nearly 20 states that have enacted new laws or regulations specific to biosimilar substitution and dispensing as of the end of last year. According to a recent tally by the National Conference of State Legislatures, at least 10 bills related to biosimilars (either newly filed or carried over from 2015) are pending this spring, many of which are very similar to laws already in effect in other states.

We are reporting that the “pending bills” number is 10 rather than 11, as the NCSL currently indicates, because the Kentucky legislature has joined several of its neighbors (Illinois, Indiana, Tennessee, and Virginia) in overwhelmingly approving an automatic biosimilar substitution law. On March 29th, the bill was delivered to the Governor for signing, which he is expected to do. Continue Reading Biosimilar Developments Continue at a Rapid Pace

Tuesday, February 9th was a busy day for Korean biologics company Celltrion Inc. The company had its proposed biosimilar CT-P13 before the FDA Arthritis Advisory Committee as well as a hearing in federal court in Massachusetts as part of the patent dispute with the manufacturer of the reference biologic, Remicade (infliximab), Janssen Biotech. At the end of the day, CT-P13 – which would be the first monoclonal antibody approved under the FDA’s biosimilar program – received the support of Arthritis Advisory Committee members. The outcome of yesterday’s hearing in the patent litigation remains unknown. When factual issues are not in dispute, FDA typically follows the advice of its expert advisory committees on approval and/or restrictions on new products, so we expect final approval of the Celltrion product in the coming months. Remicade is a blockbuster drug, with estimates of over $4 billion in sales annually in the U.S. alone, so the anticipated approval of a biosimilar version of infliximab has significance for health care providers, payors, and patients as well as investors. Our colleague Tom Wintner talks more about these developments today on the Global IP Matters Blog, available here.

For further developments in the biosimilars arena tune in to the Mintz Levin biosimilars webinar series (register here), the next installment of which is taking place on February 25 at 3pm ET.

Mintz Levin is running a series of webinars to educate our clients and friends on developments in the biosimilars space. A cross-practice team of professionals from the IP, Health and Litigation sections are collaborating to present on Patent Prosecution, Health Regulatory, FDA, Patent Litigation, Transactional and Products Liability issues. Anyone working in the biotechnology space, as well as pharmacy payors and health care providers who may be administering or dispensing biosimilars to their patients, will be interested in these presentations. The first webinar on January 7, 2016 will provide a legal and regulatory overview of the biosimilars industry and will feature Terri Shieh-Newton, PhD, and Joanne Hawana.

Looking back on 2015, it’s apparent that this was another very busy year for the Food and Drug Administration (FDA or Agency), whose oversight responsibilities are estimated to touch 25% of American consumers’ spending on various regulated products. There was no shortage of significant Agency actions in 2015 related to therapeutic and diagnostic products, which include traditional chemical drugs, biological products, medical devices and diagnostic tests, and even stem cell therapies and human tissue products. Also noteworthy is that FDA is reporting that as of December 14th it had granted approval to 42 groundbreaking new drugs (called “new molecular entities” or NMEs) and therapeutic biological products during the calendar year. The figure so far for this year beats 2014’s final count of 41 approved NMEs and far exceeds the prior year’s total of 27 NMEs. This post will highlight some of FDA’s significant actions this year and provide our thoughts about what next year may bring for FDA-regulated entities.Continue Reading FDA Legal and Regulatory – 2015 Year In Review

Today, members of the Senate Health, Education, Labor & Pensions (HELP) Committee will have an opportunity to hear from and question Dr. Janet Woodock, the director of FDA’s Center for Drug Evaluation and Research (CDER), regarding the agency’s implementation of the new approval pathway for biosimilar products created under the BPCIA. Dr. Woodcock is listed as the only person who will be presenting to the HELP Committee. Continue Reading Senators to Receive Update on Biosimilar Implementation from CDER’s Woodcock

Associate Editors

Mintz Levin’s Health Law Practice

As the health care and life sciences industries continue to undergo sweeping regulatory change, your company might be facing unprecedented structural and operational challenges. Heightened government scrutiny of industry practices certainly adds to the complexity of operating in the market for all providers, payors, manufacturers, distributors, and suppliers.Read More